TWI657791B - Ophthalmic surgical instrument with internal frame and external coating - Google Patents

Ophthalmic surgical instrument with internal frame and external coating Download PDF

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Publication number
TWI657791B
TWI657791B TW104108802A TW104108802A TWI657791B TW I657791 B TWI657791 B TW I657791B TW 104108802 A TW104108802 A TW 104108802A TW 104108802 A TW104108802 A TW 104108802A TW I657791 B TWI657791 B TW I657791B
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Taiwan
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instrument
coating
tip
inner frame
ophthalmic surgical
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TW104108802A
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Chinese (zh)
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TW201542157A (en
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菲立普 夏勒
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瑞士商諾華公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B23MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23PMETAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
    • B23P13/00Making metal objects by operations essentially involving machining but not covered by a single other subclass
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B23MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23PMETAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
    • B23P17/00Metal-working operations, not covered by a single other subclass or another group in this subclass
    • B23P17/04Metal-working operations, not covered by a single other subclass or another group in this subclass characterised by the nature of the material involved or the kind of product independently of its shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/4998Combined manufacture including applying or shaping of fluent material
    • Y10T29/49982Coating
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/4998Combined manufacture including applying or shaping of fluent material
    • Y10T29/49982Coating
    • Y10T29/49984Coating and casting
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/4998Combined manufacture including applying or shaping of fluent material
    • Y10T29/49982Coating
    • Y10T29/49986Subsequent to metal working
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/4998Combined manufacture including applying or shaping of fluent material
    • Y10T29/49988Metal casting
    • Y10T29/49989Followed by cutting or removing material

Abstract

一種製造外科手術裝置的方法可包括:產生限定一器械尖端之一內部結構的一第一內部框架;用一第一塗層覆蓋該第一內部框架之至少一部分,以限定該器械尖端之一外表面;及產生一器械主體,以使得該器械尖端之一近端位於該器械主體之一遠端。一種眼外科手術器械可包括:一器械主體;及配置在該器械主體之一遠端的一器械尖端,該器械尖端包括沿該器械主體之一縱軸線性延伸的一第一部分及自該第一部分傾斜延伸的一第二部分,該第二部分的形狀呈弓形;且其中該器械尖端包括一第一內部框架及覆蓋該第一內部框架的一第一塗層。 A method of manufacturing a surgical device may include generating a first internal frame defining an internal structure of an instrument tip; and covering at least a portion of the first internal frame with a first coating to define an exterior of the instrument tip. A surface; and creating an instrument body such that a proximal end of the instrument tip is located at a distal end of the instrument body. An ophthalmic surgical instrument may include: an instrument main body; and an instrument tip disposed at a distal end of the instrument main body, the instrument tip including a first portion extending linearly along a longitudinal axis of the instrument main body, and a portion extending from the first portion A second portion extending obliquely, the shape of the second portion is arcuate; and wherein the instrument tip includes a first inner frame and a first coating covering the first inner frame.

Description

具有內部框架及外部塗層的眼外科手術器械 Ophthalmic surgery instrument with internal frame and external coating

本文所揭示的實施例係關於眼外科手術器械。更明確言之,本文所描述的實施例係關於一種器械尖端,其具有限定內部結構的內部框架及限定外表面的外部塗層。 The embodiments disclosed herein relate to ophthalmic surgical instruments. More specifically, the embodiments described herein relate to an instrument tip having an inner frame defining an internal structure and an outer coating defining an outer surface.

眼外科手術器械可包括被外科醫師用來操縱患者解剖結構(例如,患者眼睛的一或多個層)之複雜遠端尖端。此等器械尖端的設計可係小邊緣半徑所限定的自由形成表面與其他嚴苛的設計特徵的組合。通常,該等器械尖端係利用人工製程來手工製造。例如,該等器械尖端可經手工輥壓、彎曲、磨削、拋光等,以加工並確保表面光滑且沒有刃口或毛邊。因此,製造會極為費力及費時。 An ophthalmic surgical instrument may include a complex distal tip used by a surgeon to manipulate the patient's anatomy (eg, one or more layers of the patient's eye). The design of these instrument tips can be a combination of a free-form surface defined by a small edge radius and other demanding design features. Generally, these device tips are manufactured manually using a manual process. For example, the tip of these instruments can be manually rolled, bent, ground, polished, etc. to process and ensure that the surface is smooth and free of cutting edges or burrs. Therefore, manufacturing can be extremely laborious and time consuming.

該等器械尖端通常係用全金屬(例如,不鏽鋼)製成,以確保組件具有適當的彎曲剛性。此外,金屬器械尖端可直接接觸患者的解剖結構。因此,所用的材料可具有嚴苛的技術要求(例如,可撓性、剛性、孔隙度、硬度、密度等),從而導致高昂的貨幣支出。由於在貨幣及時間方面的高材料及製造成本,因此製造可棄式或一次性使用的器械尖端在經濟上係不可行。 These instrument tips are usually made of all-metal (e.g., stainless steel) to ensure that the component has the proper flexural rigidity. In addition, the metal instrument tip can directly contact the patient's anatomy. As a result, the materials used can have stringent technical requirements (e.g., flexibility, rigidity, porosity, hardness, density, etc.), resulting in high currency expenditures. Due to the high material and manufacturing costs in terms of money and time, it is not economically feasible to manufacture disposable or single-use instrument tips.

顯微手术器械另外難以用手工製造及同時滿足所需的技術要求,因為其等極小。例如,在無瓣屈光手術中,一種眼外科手術器械微 透鏡操縱器可用於在藉由UV飛秒雷射(Femtolaser)處理角膜後使微透鏡脫層。此外科手術器械之特徵可係其用於操縱眼睛之個別層之尖端的複雜形狀。其他眼外科手術器械可類似地包括具有高技術要求的複雜尖端設計。 Microsurgical instruments are also difficult to manufacture by hand and simultaneously meet the required technical requirements because they are extremely small. For example, in valveless refractive surgery, an ophthalmic surgical instrument The lens manipulator can be used to delaminate the microlenses after treating the cornea with a UV femtolaser. A surgical instrument may be characterized by the complex shape of the tips of its individual layers for manipulating the eye. Other ophthalmic surgical instruments may similarly include sophisticated tip designs with high technical requirements.

所提出的解決方法利用獨特的解決方法來滿足尚未滿足的醫療需求,以提供具有內部框架及外部塗層之眼外科手術器械尖端,其等可更快及更具成本效益地製造,同時能夠產生複雜形狀並滿足所需的技術要求。 The proposed solution utilizes unique solutions to meet unmet medical needs to provide an ophthalmic surgical instrument tip with an internal frame and an external coating, which can be manufactured faster and more cost-effectively, while producing Complex shapes and meet the required technical requirements.

與某些實施例一致,一種製造眼外科手術器械的方法包括:產生限定器械尖端之內部結構的第一內部框架;用第一塗層覆蓋該第一內部框架之至少一部分,以限定該器械尖端的外表面;及產生具有近端及遠端的器械主體,以使得該器械尖端的近端位於該器械主體的遠端。 Consistent with certain embodiments, a method of manufacturing an ophthalmic surgical instrument includes: generating a first internal frame defining an internal structure of the instrument tip; and covering at least a portion of the first internal frame with a first coating to define the instrument tip An outer surface of the instrument; and generating an instrument body having a proximal end and a distal end such that the proximal end of the instrument tip is located at the distal end of the instrument body.

與某些實施例一致,一種眼外科手術器械包括:具有近端、遠端及縱軸的器械主體;及配置在該器械主體之遠端的器械尖端,該器械尖端包括沿該器械主體的縱軸線性延伸的第一部分及自該第一部分傾斜延伸的第二部分,該第二部分的形狀呈弓形;且其中該器械尖端包括第一內部框架及覆蓋該第一內部框架的第一塗層。 Consistent with certain embodiments, an ophthalmic surgical instrument includes: an instrument body having a proximal end, a distal end, and a longitudinal axis; and an instrument tip disposed at a distal end of the instrument body, the instrument tip including a longitudinal direction along the instrument body The first portion extending axially and the second portion extending obliquely from the first portion are arcuate in shape; and wherein the instrument tip includes a first inner frame and a first coating covering the first inner frame.

與某些實施例一致,一種製造眼外科手術器械的方法包括:產生限定器械尖端之內部結構的內部框架,該器械尖端具有遠端、線性第一部分、自該第一部分傾斜延伸的弓形第二部分及位於該遠端的扁平部分;使用塗層產生器械主體,該器械主體具有縱軸且該器械主體的外表面包含表面特徵;及在產生該器械主體的同時,使用塗層覆蓋該內部框架,以限定該器械尖端的外表面,其中在垂直於該器械主體之縱軸的平面內之該內部框架及塗層的橫截面輪廓沿該縱軸的至少一部分限定不同的形狀。 Consistent with certain embodiments, a method of manufacturing an ophthalmic surgical instrument includes generating an internal frame defining an internal structure of an instrument tip having a distal end, a linear first portion, and an arcuate second portion extending obliquely from the first portion. And a flat portion located at the distal end; using a coating to produce an instrument body having a longitudinal axis and the outer surface of the instrument body including surface features; and, while generating the instrument body, covering the inner frame with a coating, To define the outer surface of the instrument tip, wherein the cross-sectional profile of the inner frame and coating in a plane perpendicular to the longitudinal axis of the instrument body defines different shapes along at least a portion of the longitudinal axis.

本揭示案的其他態樣、特徵及優點將自以下詳細描述變得顯而易見。 Other aspects, features, and advantages of this disclosure will become apparent from the following detailed description.

100、200、300‧‧‧方法 100, 200, 300‧‧‧ methods

110、120、130、210、220、230、240、250、310、320‧‧‧步驟 110, 120, 130, 210, 220, 230, 240, 250, 310, 320‧‧‧ steps

400‧‧‧眼外科手術器械 400‧‧‧ Ophthalmic surgery instruments

420‧‧‧器械主體 420‧‧‧device body

422‧‧‧主體內部框架 422‧‧‧Main Internal Frame

424‧‧‧塗層 424‧‧‧Coated

426‧‧‧遠端 426‧‧‧Remote

430‧‧‧縱軸 430‧‧‧Vertical axis

440‧‧‧器械尖端 440‧‧‧ instrument tip

442‧‧‧尖端內部框架 442‧‧‧ sophisticated internal frame

444‧‧‧塗層 444‧‧‧Coated

446‧‧‧第一部分 446‧‧‧Part I

448‧‧‧附接機構 448‧‧‧ Attachment

450‧‧‧第二部分 450‧‧‧ Part Two

452‧‧‧扁平部分 452‧‧‧ flat section

454‧‧‧遠端 454‧‧‧Remote

456‧‧‧近端 456‧‧‧ proximal

460‧‧‧統一內部框架 460‧‧‧Unified internal framework

圖1係說明製造眼外科手術器械之方法的流程圖。 FIG. 1 is a flowchart illustrating a method of manufacturing an ophthalmic surgical instrument.

圖2係說明製造眼外科手術器械之方法的流程圖。 FIG. 2 is a flowchart illustrating a method of manufacturing an ophthalmic surgical instrument.

圖3係說明製造眼外科手術器械之方法的流程圖。 FIG. 3 is a flowchart illustrating a method of manufacturing an ophthalmic surgical instrument.

圖4係說明眼外科手術器械之器械尖端之內部框架的圖解。 Figure 4 is a diagram illustrating the internal frame of the instrument tip of an ophthalmic surgical instrument.

圖5a係說明眼外科手術器械之器械尖端的圖解。 Figure 5a is a diagram illustrating the instrument tip of an ophthalmic surgical instrument.

圖5b係說明眼外科手術器械之器械尖端的圖解。 Figure 5b is a diagram illustrating the instrument tip of an ophthalmic surgical instrument.

圖6係說明眼外科手術器械之器械尖端之橫截面視圖的圖解。 Figure 6 is a diagram illustrating a cross-sectional view of the instrument tip of an ophthalmic surgical instrument.

圖7a係說明眼外科手術器械之器械主體的圖解。 Fig. 7a is a diagram illustrating an instrument body of an ophthalmic surgical instrument.

圖7b係說明眼外科手術器械之器械主體之內部框架的圖解。 Figure 7b is a diagram illustrating the internal frame of the instrument body of the ophthalmic surgical instrument.

圖7c係說明眼外科手術器械之器械主體的圖解。 Fig. 7c is a diagram illustrating the instrument main body of the ophthalmic surgical instrument.

圖8係說明眼外科手術器械之器械尖端及器械主體之統一內部框架的圖解。 FIG. 8 is a diagram illustrating a unified internal frame of an instrument tip and an instrument body of an ophthalmic surgical instrument.

圖9a係說明眼外科手術器械的圖解。 Figure 9a is a diagram illustrating an ophthalmic surgical instrument.

圖9b係說明眼外科手術器械的圖解。 Figure 9b is a diagram illustrating an ophthalmic surgical instrument.

在圖式中,具有相同名稱的元件具有相同或類似的功能。 In the drawings, elements with the same name have the same or similar functions.

在以下描述中,闡述描述某些實施例之具體細節。然而,熟悉此項技術者應了解,所揭示的實施例可在缺少此等具體細節之一些或全部的情況下得以實現。所提出的具體實施例係意圖說明,而非限制。熟 悉此項技術者可意識到其他材料雖未在本文中明確描述,但在本揭示案之範圍及精神內。 In the following description, specific details are described that describe certain embodiments. However, those skilled in the art will appreciate that the disclosed embodiments may be practiced without some or all of these specific details. The specific embodiments presented are intended to be illustrative, not limiting. Cooked Those skilled in the art will recognize that other materials, although not explicitly described herein, are within the scope and spirit of this disclosure.

本揭示案描述一種眼外科手術器械尖端,其具有包覆有塑膠或塗層的金屬骨架或內部框架。該內部框架可確保滿足對可撓性及/或剛性的技術要求,而該器械尖端的複雜外部輪廓可由塗層來限定。根據本揭示案所製造的器械可用於屈光手術、白內障手術、玻璃體視網膜手術及/或其他眼外科手術程序。 The present disclosure describes an ophthalmic surgical instrument tip having a metal skeleton or internal frame covered with plastic or a coating. The internal frame ensures that technical requirements for flexibility and / or rigidity are met, while the complex external contour of the instrument tip can be defined by a coating. Devices made in accordance with the present disclosure can be used in refractive surgery, cataract surgery, vitreoretinal surgery, and / or other ophthalmic surgery procedures.

該內部框架可使用相對便宜的組件如下料、線蝕或金屬注射成型(MIM)的金屬部件來製造。該內部框架可用作注射成型製程中之嵌入物,該注射成型製程使用塗層覆蓋內部框架,以限定外部輪廓。本揭示案描述具有與手工製造器械相當的技術性質,但材料及製造成本更低的器械之製造。因此,製造可棄式或一次性使用的器械係更可行。 The internal frame can be manufactured using relatively inexpensive components such as blanks, wire erosion or metal injection molded (MIM) metal parts. The inner frame can be used as an insert in an injection molding process that covers the inner frame with a coating to define the outer contour. This disclosure describes the manufacture of devices that have technical properties comparable to handmade devices, but with lower materials and manufacturing costs. Therefore, it is more feasible to make disposable or disposable devices.

本揭示案的裝置、系統及方法提供許多優點,包括:(1)與手工加工相比,基於相對簡單的材料/工業加工,更快速、較省力及更具成本效益的製造;(2)更具成本效益的材料,如技術要求不太嚴格的低成本散裝貨品;(3)使用注射成型,設計複雜性不受限制;(4)使用已確立材料/工業加工(模切、彎曲、注射成型等),加工穩定性高;(6)使用相同加工步驟,在製造器械之多個組件如主體及尖端時具有靈活性;(7)使用已確立材料/工業加工之自動化製造;及(8)基於手術目的選擇內部框架及外部塗層材料的靈活性。 The devices, systems, and methods of this disclosure provide many advantages, including: (1) faster, less labor-intensive, and more cost-effective manufacturing based on relatively simple materials / industrial processing compared to manual processing; (2) more Cost-effective materials, such as low-cost bulk goods with less stringent technical requirements; (3) the use of injection molding for unlimited design complexity; (4) the use of established materials / industrial processing (die cutting, bending, injection molding) Etc.), high processing stability; (6) the use of the same processing steps, flexibility in manufacturing multiple components of the device such as the main body and the tip; (7) automated manufacturing using established materials / industrial processing; and (8) Flexibility in selecting internal frame and external coating materials based on surgical purpose.

圖1至3分別提供製造眼外科手術器械400(圖9a9b)之方法100、200及300的流程圖。參照圖4至9b可進一步理解方法100、200及300,圖4至9b說明在方法100、200及300之各個階段中的器械400。圖9a9b可說明完全組裝的器械400。器械400包括器械主體420及器械 尖端440。方法100可描述其中器械尖端440包括且器械主體420不包括內部框架及外部塗層之器械400的製造。方法100及200可描述其中器械主體420及器械尖端440各包括內部框架及外部塗層之器械400的製造。在方法100中,器械主體420及器械尖端440係分離的組件,而在方法200中,器械主體及器械尖端係單一組件。 1 to 3 provide flowcharts of methods 100, 200, and 300 of manufacturing an ophthalmic surgical instrument 400 ( FIGS. 9a and 9b, respectively ). The methods 100, 200, and 300 can be further understood with reference to FIGS. 4 to 9b , which illustrate the instrument 400 in various stages of the methods 100, 200, and 300. Figures 9a and 9b can illustrate a fully assembled instrument 400. The instrument 400 includes an instrument main body 420 and an instrument tip 440. The method 100 may describe the manufacture of an instrument 400 in which the instrument tip 440 includes and the instrument body 420 does not include an inner frame and an outer coating. The methods 100 and 200 may describe the manufacture of an instrument 400 in which the instrument body 420 and the instrument tip 440 each include an inner frame and an outer coating. In the method 100, the instrument body 420 and the instrument tip 440 are separate components, and in the method 200, the instrument body and the instrument tip are single components.

參照圖1,方法100包括:在步驟110下,產生器械尖端的內部框架。方法100進一步包括:在步驟120下,使用第一塗層覆蓋尖端內部框架,以限定器械尖端的外表面。如圖4至6圖8至9b所示,器械尖端440具有適用於在外科手術程序期間接觸患者眼睛的一或多個層的尺寸及形狀。尖端內部框架442可限定器械尖端440的內部結構。塗層444可限定器械尖端440的外表面。使用塗層來限定外表面可允許以更快速及更具成本效益的方式產生複雜的尖端形狀(與例如輥壓、彎曲、銼削及拋光全金屬器械尖端440相比)。同時,尖端內部框架442可提供當塗層444在外科手術程序期間與患者解剖結構接觸時,器械尖端440所必需的可撓性及/或剛性。提供必需的可撓性及/或剛性可允許外科醫師手部的移動傳遞至器械尖端。塗層444提供額外的可撓性及/或剛性。塗層444亦可經選擇用來滿足各種技術要求,包括(例如)表面粗糙度、表面結構、孔隙度、硬度、密度等。 Referring to FIG. 1 , the method 100 includes generating an internal frame of the instrument tip at step 110. The method 100 further includes, under step 120, covering the inner frame of the tip with a first coating to define an outer surface of the instrument tip. As Figures 4 to 6 and 8 to 9b, the tip of the instrument 440 has a size and shape suitable for a plurality of layers or during a surgical procedure in contact with the patient's eye. The tip internal frame 442 may define the internal structure of the instrument tip 440. The coating 444 may define an outer surface of the instrument tip 440. Using a coating to define the outer surface may allow for the creation of complex tip shapes (as compared to, for example, rolling, bending, filing, and polishing all-metal instrument tip 440) in a faster and more cost-effective manner. At the same time, the tip inner frame 442 may provide the flexibility and / or rigidity necessary for the instrument tip 440 when the coating 444 is in contact with the patient's anatomy during a surgical procedure. Providing the necessary flexibility and / or rigidity may allow movement of the surgeon's hand to be transmitted to the instrument tip. The coating 444 provides additional flexibility and / or rigidity. The coating 444 may also be selected to meet various technical requirements, including, for example, surface roughness, surface structure, porosity, hardness, density, and the like.

尖端內部框架442可由第一材料製成或包括第一材料,如金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料。可選擇該第一材料,以使得器械尖端440具有足夠用於外科手術程序的可撓性及/或剛性。由於塗層444而非尖端內部框架442直接接觸患者解剖結構,及因為塗層444額外滿足器械尖端440的技術要求,因此可選擇具成本效益的材料用於尖端內部框架442(例如,技術要求不太嚴格的 低成本散裝貨品)。 The tip inner frame 442 may be made of or include a first material, such as metal, metal alloy, ceramic, composite, polymer, plastic, elastomer, and / or any other suitable material. This first material may be selected so that the instrument tip 440 is flexible and / or rigid enough for a surgical procedure. Because the coating 444 directly contacts the patient's anatomy rather than the tip internal frame 442, and because the coating 444 additionally meets the technical requirements of the instrument tip 440, cost-effective materials can be selected for the tip internal frame 442 (e.g., the technical requirements are not Too strict Low-cost bulk goods).

覆蓋尖端內部框架442(步驟120)可包括使用第一塗層444如金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料進行注射成型。塗層444可根據手術目的來選擇。例如,使用非金屬塗層444可提供器械尖端440與患者解剖結構(例如,角膜基質)之間的較低摩擦力。尖端內部框架442可用作注射成型製程中的嵌入物。在其他實施例中,可利用其他材料/工業加工對尖端內部框架442覆蓋塗層444。 Covering the tip inner frame 442 (step 120) may include injection molding using a first coating 444 such as metal, metal alloy, ceramic, composite, polymer, plastic, elastomer, and / or any other suitable material. The coating 444 may be selected according to the purpose of the surgery. For example, using a non-metallic coating 444 may provide lower friction between the instrument tip 440 and the patient's anatomy (e.g., corneal stroma). The tip inner frame 442 can be used as an insert in an injection molding process. In other embodiments, the tip inner frame 442 may be covered with a coating 444 using other materials / industrial processes.

在某些實施例中,尖端內部框架442可係實心。因此,用塗層444覆蓋尖端內部框架442(步驟120)包括用塗層444圍包尖端內部框架442。在某些實施例中,尖端內部框架442可包括塗層444可透過的空間。因此,用塗層444覆蓋尖端內部框架442(步驟120)可包括用塗層444填充空間並圍包尖端內部框架442。 In some embodiments, the tip inner frame 442 may be solid. Accordingly, covering the tip inner frame 442 with the coating 444 (step 120) includes wrapping the tip inner frame 442 with the coating 444. In some embodiments, the tip inner frame 442 may include a space permeable to the coating 444. Accordingly, covering the tip inner frame 442 with the coating 444 (step 120) may include filling the space with the coating 444 and enclosing the tip inner frame 442.

器械尖端440在不同實施例中可根據例如不同手術程序對器械的需求而具有不同的形狀。例如,器械尖端440的一或多個部分可係筆直、有角度、彎曲、弓形等;包括彎鉤等;及/或限定鑷子、刀片、剪刀等。尖端內部框架442可限定器械尖端440所需之任何形狀的內部結構。塗層444可限定器械尖端440所需之任何形狀的外表面。本文描述用於無瓣屈光手術之器械尖端440之一例示性實施例。應了解,本揭示案之教示可應用於不同眼外科手術程序及其他醫療程序中所用的各種器械。 The instrument tip 440 may have different shapes in different embodiments depending on, for example, the requirements of the instrument for different surgical procedures. For example, one or more portions of the instrument tip 440 may be straight, angled, curved, bowed, etc .; include hooks and the like; and / or define tweezers, blades, scissors, etc. The tip internal frame 442 may define any shape of internal structure required for the instrument tip 440. The coating 444 may define an outer surface of any shape required by the instrument tip 440. Described herein is an exemplary embodiment of an instrument tip 440 for valveless refractive surgery. It should be understood that the teachings of this disclosure can be applied to various instruments used in different ophthalmic surgical procedures and other medical procedures.

圖4、5a5b所示,尖端內部框架442可包括第一部分446及第二部分450。第二部分450可在外科手術程序期間被外科醫師用來操縱患者的解剖結構。第一部分446可係大體上線性並沿器械主體420的縱軸430(圖9a9b)延伸。第二部分450可自第一部分446傾斜延伸。第二部分450可係弓形。在某些實施例中,尖端內部框架442的第二部分450 可係直線型,且塗層444可覆蓋尖端內部框架442之第二部分450,以使得第二部分450的外部輪廓為弓形。在某些實施例中,僅第二部分450係經塗層444覆蓋。在某些實施例中,第一及第二部分446及450皆經塗層444覆蓋。對不同的外科手術器械而言,第一及第二部分446及450可具有不同形狀。例如,第二部分450可成角度,包括彎鉤等。 As FIG. 4,5a and the tip of the inner frame shown in FIG. 5b 442 may include a first portion 446 and second portion 450. The second portion 450 may be used by a surgeon to manipulate the patient's anatomy during a surgical procedure. The first portion 446 may be substantially linear and extend along the longitudinal axis 430 ( FIGS. 9a and 9b ) of the instrument body 420. The second portion 450 may extend obliquely from the first portion 446. The second portion 450 may be bowed. In some embodiments, the second portion 450 of the tip inner frame 442 may be linear and the coating 444 may cover the second portion 450 of the tip inner frame 442 such that the outer contour of the second portion 450 is arcuate. In some embodiments, only the second portion 450 is covered with a coating 444. In some embodiments, the first and second portions 446 and 450 are both covered by a coating 444. The first and second portions 446 and 450 may have different shapes for different surgical instruments. For example, the second portion 450 may be angled, including a hook and the like.

尖端內部框架442的形狀可類似於器械尖端440之所需外部輪廓。然而,尖端內部框架442的形狀可比最終的外部輪廓簡單。例如,外表面的一或多個表面特徵(例如,遠端454處的恆定小邊緣半徑)可由塗層444限定,而不用在尖端內部框架442中重複。在某些實施例中,塗層444限定器械尖端400之光滑外部輪廓。在某些實施例中,塗層444可在遠端454處限定一或多個表面特徵。該等表面特徵可包括凸起、凹陷、凹槽、脊、條紋、凸塊及/或其他紋理特徵。與塗層444限定光滑的外部輪廓時相比,該等表面特徵可改變器械尖端440與患者解剖結構之間的摩擦力及/或接觸感。 The shape of the tip inner frame 442 may be similar to the desired outer contour of the instrument tip 440. However, the shape of the tip inner frame 442 may be simpler than the final outer outline. For example, one or more surface features of the outer surface (eg, a constant small edge radius at the distal end 454) may be defined by the coating 444 without being repeated in the tip inner frame 442. In some embodiments, the coating 444 defines a smooth outer contour of the instrument tip 400. In certain embodiments, the coating 444 may define one or more surface features at the distal end 454. Such surface features may include protrusions, depressions, grooves, ridges, stripes, bumps, and / or other texture features. Such surface features may alter the friction and / or contact between the instrument tip 440 and the patient's anatomy compared to when the coating 444 defines a smooth outer contour.

尖端內部框架442可包括近端456及遠端454。尖端內部框架442之遠端454可包括扁平部分452。扁平部分452在不同實施例中可具有不同形狀,例如,實質上圓形、矩形、橢圓形、六邊形、多邊形、其組合或任何其他輪廓。與器械尖端440的其他部分相比,經塗層444覆蓋的扁平部分452可具有用於接觸患者解剖結構的額外表面積。該額外表面可有利於在外科手術程序期間操縱例如患者眼睛的一或多個層。扁平部分452在垂直於縱軸430(圖9a9b)之方向上的尺寸(例如,半徑或寬度)大小可大於第一及/或第二部分446及450之尺寸(例如,半徑或寬度)大小。塗層444可限定扁平部分452。例如,如圖5a所示,在某些實施例中,塗層444限定扁平部分452的內部及外部,以使得尖端內部框架442不貫穿扁平部分 452。如圖5b所示,在某些實施例中,尖端內部框架442(例如,第二部分450)貫穿扁平部分452。在各種實施例中,器械尖端440可具有約1mm與50mm、10mm與40mm、20mm與40mm及30mm與40mm之間的長度。在各種實施例中,器械尖端440可具有約0.1mm與2mm、0.1mm與1mm、0.1mm與0.5mm及0.1mm與0.3mm之間的直徑。在各種實施例中,塗層444在器械尖端440的遠端454處可具有約0.01mm與1mm、0.01mm與0.5mm、0.01mm與0.25mm及0.01mm與0.15mm之間的厚度。 The tip internal frame 442 may include a proximal end 456 and a distal end 454. The distal end 454 of the tip inner frame 442 may include a flat portion 452. The flat portion 452 may have different shapes in different embodiments, for example, substantially circular, rectangular, oval, hexagonal, polygonal, a combination thereof, or any other outline. Compared to other parts of the instrument tip 440, the flat portion 452 covered by the coating 444 may have additional surface area for contacting the patient's anatomy. This additional surface may facilitate manipulation of one or more layers, such as the patient's eye, during a surgical procedure. The size (e.g., radius or width) of the flat portion 452 in a direction perpendicular to the longitudinal axis 430 ( FIGS. 9a and 9b ) may be larger than the size (e.g., radius or width) of the first and / or second portions 446 and 450 size. The coating 444 may define a flat portion 452. For example, as shown in Figure 5a, in certain embodiments, the coating 444 defining inner and outer flat portion 452 of the inner frame 442 so that the tip does not penetrate the flat portion 452. As shown in FIG. 5b, in some embodiments, the tip of the internal frame 442 (e.g., the second portion 450) through the flat portion 452. In various embodiments, the instrument tip 440 may have a length between about 1 mm and 50 mm, 10 mm and 40 mm, 20 mm and 40 mm, and 30 mm and 40 mm. In various embodiments, the instrument tip 440 may have a diameter between about 0.1 mm and 2 mm, 0.1 mm and 1 mm, 0.1 mm and 0.5 mm, and 0.1 mm and 0.3 mm. In various embodiments, the coating 444 may have a thickness at the distal end 454 of the instrument tip 440 of between about 0.01 mm and 1 mm, 0.01 mm and 0.5 mm, 0.01 mm and 0.25 mm, and 0.01 mm and 0.15 mm.

尖端內部框架442在垂直於縱軸430(圖9a9b)之平面內可具有形狀為圓形、矩形、橢圓形、多邊形、其組合或任何其他輪廓的橫截面。例如,如圖6(其係圖5a5b沿線A-A之橫截面視圖)所示,尖端內部框架442具有圓角矩形橫截面。類似地,塗層444在垂直於縱軸430(圖9a9b)之平面內可具有形狀為圓形、矩形、橢圓形、多邊形、其組合或任何其他輪廓的橫截面。例如,如圖6所示,塗層444具有橢圓形橫截面。因此,在某些實施例中,如圖6所示,尖端內部框架442及塗層444的橫截面輪廓限定不同的形狀。在某些實施例中,尖端內部框架442及塗層444的橫截面輪廓限定相同或類似的形狀(例如,皆為橢圓形、皆為矩形等)。 The tip inner frame 442 may have a cross section that is circular, rectangular, oval, polygonal, a combination thereof, or any other contour in a plane perpendicular to the longitudinal axis 430 ( FIGS. 9a and 9b ). For example, as shown in Figure 6 (5a and 5b a cross-sectional view thereof along line AA of FIG.), The tip of the inner frame 442 having a rounded rectangular cross section. Similarly, the coating 444 may have a cross-section that is circular, rectangular, oval, polygonal, a combination thereof, or any other contour in a plane perpendicular to the longitudinal axis 430 ( FIGS. 9a and 9b ). For example, as shown in FIG. 6, the coating 444 has an oval cross-section. Thus, in some embodiments, as shown in FIG. 6, the cross-sectional profile of the tip of the inner frame 442 and the coating 444 define a different shape. In some embodiments, the cross-sectional profiles of the tip inner frame 442 and the coating 444 define the same or similar shapes (eg, both oval, rectangular, etc.).

再參照圖1,方法100之步驟130可包括產生器械主體。如圖7a7b9a9b中所示,器械主體420具有適合使用者(例如,外科醫師)在外科手術程序期間握持之尺寸及形狀。器械主體420可係單一組件。例如,如圖7a所示,可使用無明顯內部框架或外部塗層之器械主體420。圖7a的器械主體420可手工形成或機械製造。例如,製造器械主體420可包括車削(例如,在車床上)、注射成型、磨削、3D列印或任何其他合適的製造方法。在某些實施例中,器械420可係金屬組件。在某些實施例中,可使用第一塗層444限定器械主體420。塗層424及/或塗層444可被描述 為模塑材料,如用於注射成型製程的模塑材料。例如,器械主體420之內部結構及外表面可由第一塗層444限定。器械主體420可係實心或空心。在某些實施例中,器械主體420係使用注射成型製程或其他合適的材料/工業製程來產生。用第一塗層444覆蓋尖端內部框架442(步驟120)可實質上與產生器械主體420(步驟130)同時發生(例如,在相同的加工步驟期間)。尖端內部框架442可用作注射成型用嵌件模具。第一塗層444之薄層可覆蓋具有第一塗層444之尖端內部框架442,以限定遠端454之外表面,且器械主體420可用第一塗層444模塑成單件。在一實施例中,器械400(圖9a)可如此形成。方法100可額外包括一或多個處理步驟(例如,拋光、雷射標記、消毒、包裝等)。 Referring again to FIG. 1 , step 130 of method 100 may include generating an instrument body. As FIG. 7A,, the instrument body, 7b 9a and 9b as shown in 420 for having a user (e.g., surgeon) the size and shape of the grip during a surgical procedure. The instrument body 420 may be a single component. For example, as shown in Figure 7a, using no inner frame or outer coating of the instrument body 420. The instrument body 420 of Fig. 7a may be formed manually or mechanically. For example, manufacturing the instrument body 420 may include turning (eg, on a lathe), injection molding, grinding, 3D printing, or any other suitable manufacturing method. In some embodiments, the instrument 420 may be a metal component. In some embodiments, the first coating 444 may be used to define the instrument body 420. The coating 424 and / or the coating 444 may be described as a molding material, such as a molding material used in an injection molding process. For example, the internal structure and external surface of the instrument body 420 may be defined by the first coating 444. The instrument body 420 may be solid or hollow. In some embodiments, the instrument body 420 is produced using an injection molding process or other suitable material / industrial process. Covering the tip inner frame 442 with the first coating 444 (step 120) may occur substantially simultaneously (e.g., during the same processing step) as generating the instrument body 420 (step 130). The tip inner frame 442 can be used as an insert mold for injection molding. The thin layer of the first coating 444 may cover the tip inner frame 442 with the first coating 444 to define the outer surface of the distal end 454, and the instrument body 420 may be molded into a single piece with the first coating 444. In one embodiment, the instrument 400 ( FIG. 9a ) may be so formed. The method 100 may additionally include one or more processing steps (eg, polishing, laser marking, sterilization, packaging, etc.).

圖2說明用於製造眼外科手術器械的方法200,該眼外科手術器械具有各包括內部框架及外部塗層之器械主體及器械尖端。方法200之步驟210可包括產生器械尖端的內部框架。方法200之步驟220可進一步包括用外部塗層覆蓋尖端內部框架,以限定外表面。尖端內部框架442可以類似於針對方法100之步驟110(圖1)所述的方式產生。例如,尖端內部框架442可由金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料製成,或包括此等材料。尖端內部框架442可以類似於針對方法100之步驟120(圖1)所述的方式經外部塗層覆蓋。例如,覆蓋尖端內部框架442(步驟220)可包括使用塗層如金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料進行注射成型。 FIG. 2 illustrates a method 200 for manufacturing an ophthalmic surgical instrument having an instrument body and an instrument tip each including an inner frame and an outer coating. Step 210 of method 200 may include generating an internal frame of the instrument tip. Step 220 of method 200 may further include covering the inner frame of the tip with an outer coating to define an outer surface. The tip internal frame 442 may be generated in a manner similar to that described for step 110 ( FIG. 1 ) of method 100. For example, the tip inner frame 442 may be made of or include metal, metal alloys, ceramics, composites, polymers, plastics, elastomers, and / or any other suitable materials. The tip inner frame 442 may be covered with an outer coating in a manner similar to that described for step 120 (FIG. 1) of method 100. For example, covering the tip inner frame 442 (step 220) may include injection molding using a coating such as metal, metal alloy, ceramic, composite, polymer, plastic, elastomer, and / or any other suitable material.

方法200之步驟230可包括產生器械主體之內部框架。圖7b7c9b可說明主體內部框架422。主體內部框架422可限定器械主體420之內部結構。方法200之步驟240(圖2)可進一步包括用第二塗層覆蓋主體內部框架,以限定器械主體的外表面。與器械主體之主體內部框架422 及相應塗層424相關之步驟230及240可類似於針對尖端內部框架442及相應塗層444之步驟210及220。例如,主體內部框架422可由第二材料如金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料製成,或包括第二材料。主體內部框架422及尖端內部框架442可使用相同的材料或不同的材料。覆蓋主體內部框架422(步驟240)可包括使用第二塗層424(圖7c9b)如金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料進行注射成型。第一塗層444及第二塗層424可係相同或不同。 Step 230 of method 200 may include generating an internal frame of the instrument body. Figures 7b , 7c and 9b illustrate the main body inner frame 422. The main body inner frame 422 may define an internal structure of the instrument main body 420. Step 240 ( FIG. 2 ) of method 200 may further include covering the main body inner frame with a second coating to define an outer surface of the instrument main body. The steps 230 and 240 related to the body inner frame 422 and the corresponding coating 424 of the instrument body may be similar to steps 210 and 220 for the tip inner frame 442 and the corresponding coating 444. For example, the main body inner frame 422 may be made of or include a second material such as metal, metal alloy, ceramic, composite, polymer, plastic, elastomer, and / or any other suitable material. The main body inner frame 422 and the tip inner frame 442 may use the same material or different materials. Covering the main body inner frame 422 (step 240) may include injection using a second coating 424 ( FIGS. 7c and 9b ) such as metal, metal alloy, ceramic, composite, polymer, plastic, elastomer, and / or any other suitable material forming. The first coating layer 444 and the second coating layer 424 may be the same or different.

圖7b7c9b所示,主體內部框架422的形狀可類似於器械主體420之所需外部輪廓。然而,主體內部框架422的形狀可比最終的外部輪廓簡單。例如,由塗層424限定的用於加強使用者緊握器械主體420之一或多個表面特徵可從主體內部框架422中省去。塗層424可限定器械主體420上的結構化表面(例如,粗糙化、凸邊、凸起/凹陷、錐體、其他表面特徵及/或其組合)。 As shown in Figure 7b, 7c and 9b, the internal shape of the body frame 422 may be similar to the instrument body 420 of a desired outer contour. However, the shape of the main body inner frame 422 may be simpler than the final outer outline. For example, one or more surface features defined by the coating 424 to enhance the user's grip on the instrument body 420 may be omitted from the body inner frame 422. The coating 424 may define a structured surface (eg, roughened, raised edges, raised / concave, cone, other surface features, and / or combinations thereof) on the instrument body 420.

再參照圖2,方法200之步驟250可包括使器械尖端與器械主體接合。在某些實施例中,尖端內部框架442可與主體內部框架422接合。例如,尖端內部框架442的近端456可經由附接機構448(圖4)機械地耦合至主體內部框架422的遠端426。附接機構448可配置在尖端內部框架442之近端456處。附接機構448可包括任何合適的機械組態,以允許器械尖端440結合至器械主體420。在其中尖端內部框架442及主體內部框架422並非分離的組件之實施例中可省去附接機構448。在圖4中,附接機構448的半徑可小於第一及/或第二部分446及450的半徑。例如,附接機構448可包括外部螺紋,其係經組態為與器械主體420之遠端426處的相應內部螺紋相配。在某些實施例中,尖端內部框架442係經組態為與器械主體 420壓入配合、滑動配合、壓縮配合、過盈配合或以其他方式接合配合。在某些實施例中,器械尖端440與器械主體420之間的連接係形封閉及/或力封閉形式。例如,在注射成型加工中,尖端內部框架442可嵌入注射成型機中,且尖端內部框架442的近端456可包覆成型。在某些實施例中,尖端內部框架442可與器械主體420的塗層424接合,或主體內部框架422可與器械尖端440的塗層444接合。在某些實施例中,可使用黏著劑使器械主體420與器械尖端440接合。當器械主體420與器械尖端440接合時,形成器械400(圖9b)。 Referring again to FIG. 2 , step 250 of method 200 may include engaging the instrument tip with the instrument body. In some embodiments, the tip inner frame 442 may be engaged with the main body inner frame 422. For example, the proximal end 456 of the tip inner frame 442 may be mechanically coupled to the distal end 426 of the main body inner frame 422 via an attachment mechanism 448 ( FIG. 4 ). The attachment mechanism 448 may be configured at the proximal end 456 of the tip inner frame 442. The attachment mechanism 448 may include any suitable mechanical configuration to allow the instrument tip 440 to be coupled to the instrument body 420. The attachment mechanism 448 may be omitted in embodiments where the tip inner frame 442 and the main body inner frame 422 are not separate components. In FIG. 4 , the radius of the attachment mechanism 448 may be smaller than the radius of the first and / or second portions 446 and 450. For example, the attachment mechanism 448 may include external threads that are configured to mate with corresponding internal threads at the distal end 426 of the instrument body 420. In some embodiments, the tip inner frame 442 is configured to press fit, slide fit, compress fit, interference fit, or otherwise engage fit with the instrument body 420. In some embodiments, the connection between the instrument tip 440 and the instrument body 420 is in a form-closed and / or force-closed form. For example, in an injection molding process, the tip inner frame 442 may be embedded in an injection molding machine, and the proximal end 456 of the tip inner frame 442 may be overmolded. In some embodiments, the tip inner frame 442 may be engaged with the coating 424 of the instrument body 420 or the body inner frame 422 may be engaged with the coating 444 of the instrument tip 440. In some embodiments, an adhesive can be used to engage the instrument body 420 with the instrument tip 440. When the instrument body 420 is engaged with the instrument tip 440, the instrument 400 is formed ( FIG. 9b ).

圖3說明用於製造具有統一內部框架之眼外科手術器械之方法300。方法300之步驟310可包括產生器械尖端及器械主體之統一內部框架。方法300之步驟320可進一步包括用外部塗層覆蓋統一內部框架,以限定外表面。如圖8所示,尖端內部框架442及主體內部框架422可包括統一組件。統一內部框架460可以類似於針對方法100之步驟110(圖1)所述的方式產生。例如,統一內部框架460可由金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料製成或包括此等材料。統一內部框架460可以類似於針對方法100之步驟120(圖1)所述的方式經外部塗層覆蓋。例如,覆蓋統一內部框架460(步驟320)可包括使用塗層如金屬、金屬合金、陶瓷、複合物、聚合物、塑膠、彈性體及/或任何其他合適材料進行注射成型。如圖89b所示,統一內部框架460的形狀可類似於器械主體420及器械尖端440之所需外部輪廓。然而,主體內部框架422的形狀可比最終的外部輪廓簡單。例如,由塗層限定之一或多個特徵(如器械尖端440之複雜形狀、器械主體420的表面特徵等)可從統一內部框架460中省去。當外部塗層覆蓋統一內部框架460時,形成器械400(圖9b)。方法300可額外包括一或多個處理步驟(例如,拋光、雷射標記、消毒、 包裝等)。 FIG. 3 illustrates a method 300 for manufacturing an ophthalmic surgical instrument having a unified internal frame. Step 310 of method 300 may include generating a unified internal frame of the instrument tip and the instrument body. Step 320 of method 300 may further include covering the unified inner frame with an outer coating to define an outer surface. For example, the tip 442 and the inner frame inside the body frame shown in FIG. 8 assembly 422 may include uniform. The unified internal framework 460 may be generated in a manner similar to that described for step 110 (FIG. 1) of the method 100. For example, the unified internal frame 460 may be made of or include metals, metal alloys, ceramics, composites, polymers, plastics, elastomers, and / or any other suitable materials. The unified internal frame 460 may be covered with an external coating in a manner similar to that described for step 120 ( FIG. 1 ) of the method 100. For example, covering the unified internal frame 460 (step 320) may include injection molding using a coating such as metal, metal alloy, ceramic, composite, polymer, plastic, elastomer, and / or any other suitable material. As shown in FIGS. 8 and 9b, the shape of a unified inner frame body 460 may be similar to the instrument 420 and instrument tip 440 of the outer contour of the desired. However, the shape of the main body inner frame 422 may be simpler than the final outer outline. For example, one or more features defined by the coating (such as the complex shape of the instrument tip 440, the surface features of the instrument body 420, etc.) may be omitted from the unified internal frame 460. When the outer coating covers the unified inner frame 460, the instrument 400 is formed ( FIG. 9b ). The method 300 may additionally include one or more processing steps (eg, polishing, laser marking, sterilization, packaging, etc.).

合適的材料/工業加工(包括下料、模塑、鑄造、機械加工、切割等)可用於產生尖端內部框架442、主體內部框架422及/或統一內部框架460,及/或用外部塗層覆蓋內部框架。例如,可使用吹氣成型、注射成型、熱壓成型、離心鑄造、熔模鑄造、永久模鑄造、砂模鑄造、殼模鑄造、磨削、車削、成型、剪切、沖壓、雷射束切割、電漿切割、射水切割、立體光刻、熔融沈積造型、選擇性雷射燒結、直接金屬雷射燒結、3D列印、擠壓、放電加工、電化學加工、電成型、彎曲、輥壓成型、旋壓、深抽製、拉伸成型等等。 Appropriate materials / industrial processing (including blanking, molding, casting, machining, cutting, etc.) can be used to produce the tip inner frame 442, the main body inner frame 422, and / or the unified inner frame 460, and / or covered with an outer coating Internal frame. For example, blow molding, injection molding, thermoforming, centrifugal casting, investment casting, permanent mold casting, sand mold casting, shell mold casting, grinding, turning, forming, shearing, stamping, laser beam cutting can be used , Plasma cutting, water jet cutting, stereolithography, fused deposition modeling, selective laser sintering, direct metal laser sintering, 3D printing, extrusion, electrical discharge machining, electrochemical machining, electroforming, bending, roll forming , Spinning, deep drawing, stretch forming and so on.

本文所描述的實施例可提供有利於製造具有複雜形狀的眼外科手術器械,同時滿足可撓性及/或剛性的所需技術要求之裝置、系統及方法。本文所描述的裝置、系統及方法可用於任何外科手術器械。以上所提供的實例僅為例示性且無意具有限制性。熟悉此項技術者可容易地設計與所揭示的實施例一致且意欲包含在本揭示案之範圍內的其他系統。因此,本申請案僅受以下申請專利範圍限制。 The embodiments described herein can provide devices, systems, and methods that facilitate the fabrication of ophthalmic surgical instruments with complex shapes while meeting the required technical requirements for flexibility and / or rigidity. The devices, systems, and methods described herein can be used with any surgical instrument. The examples provided above are illustrative only and are not intended to be limiting. Those skilled in the art can easily design other systems consistent with the disclosed embodiments and intended to be included within the scope of this disclosure. Therefore, this application is limited only by the scope of the following patent applications.

Claims (9)

一種眼外科手術器械,其包括:一器械主體,其具有一近端、一遠端及一縱軸;及一器械尖端,其配置在該器械主體之該遠端,該器械尖端包括沿該器械主體之該縱軸線性延伸的一第一部分及自該第一部分傾斜延伸的一第二部分,該第二部分的形狀呈弓形;且其中該器械尖端包括一第一內部框架及覆蓋該第一內部框架的一第一塗層,該第一內部框架的一遠端包括一扁平部分,其中該第一塗層包括選自於由下列所構成之群組的材料:金屬、陶瓷、複合物、聚合物及彈性體,其中該器械主體包括:一第二內部框架,其與該第一內部框架分離且與該第一內部框架不呈單一整體;及一第二塗層,其覆蓋該第二內部框架,其中該器械尖端包括一第一組件,且其中該器械主體包括與該第一組件分離的一第二組件。An ophthalmic surgical instrument includes: an instrument main body having a proximal end, a distal end, and a longitudinal axis; and an instrument tip configured at the distal end of the instrument main body, the instrument tip including along the instrument A first part extending linearly of the longitudinal axis of the main body and a second part extending obliquely from the first part, the shape of the second part is arcuate; and the instrument tip includes a first internal frame and covers the first internal A first coating of the frame, a distal end of the first inner frame including a flat portion, wherein the first coating includes a material selected from the group consisting of: metal, ceramic, composite, polymer And an elastomer, wherein the instrument body includes: a second internal frame that is separate from the first internal frame and does not form a single unitary body with the first internal frame; and a second coating that covers the second internal frame A frame, wherein the instrument tip includes a first component, and wherein the instrument body includes a second component separated from the first component. 如請求項1之眼外科手術器械,其中該第一塗層限定該器械尖端的一外表面。The ophthalmic surgical instrument of claim 1, wherein the first coating defines an outer surface of the instrument tip. 如請求項1之眼外科手術器械,其中在垂直於該器械主體之該縱軸的一平面內之該第一內部框架及該第一塗層之橫截面輪廓限定不同的形狀。The ophthalmic surgical instrument of claim 1, wherein the first inner frame and the cross-sectional profile of the first coating in a plane perpendicular to the longitudinal axis of the instrument body define different shapes. 如請求項1之眼外科手術器械,其中該器械尖端在一遠端處包括一扁平部分。The ophthalmic surgical instrument of claim 1, wherein the instrument tip includes a flat portion at a distal end. 如請求項1之眼外科手術器械,其中該器械主體包括該第一塗層。The ophthalmic surgical instrument of claim 1, wherein the instrument body includes the first coating. 如請求項1之眼外科手術器械,其中該等第一及第二內部框架以及該第二塗層包括金屬、陶瓷、複合物、聚合物及彈性體中之至少一者。The ophthalmic surgical instrument of claim 1, wherein the first and second inner frames and the second coating include at least one of metal, ceramic, composite, polymer, and elastomer. 如請求項1或6之眼外科手術器械,其中該金屬為金屬合金。The ophthalmic surgical instrument of claim 1 or 6, wherein the metal is a metal alloy. 如請求項1或6之眼外科手術器械,其中該聚合物為塑膠。The ophthalmic surgical instrument of claim 1 or 6, wherein the polymer is plastic. 如請求項1之眼外科手術器械,其中該第一內部框架包括該第一塗層可透過的空間。The ophthalmic surgical instrument of claim 1, wherein the first inner frame includes a space permeable to the first coating.
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